Congenital Cytomegalovirus InfectionPhase 2NCT03301415
Asymptomatic Congenital CMV Treatment
A Phase 2 study testing Valganciclovir in people with Congenital Cytomegalovirus Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in United States.
Trial summary
This is a phase II, open-label trial to evaluate valganciclovir as a treatment to prevent development of sensorineural hearing loss (SNHL) in infants with asymptomatic congenital cytomegalovirus (CMV) infection. Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Congenital Cytomegalovirus Infection
- What is being tested?
- Valganciclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 9 sitesUnited States
- Study dates
- 21 Aug 2019to 5 Nov 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parent(s)/legal guardian(s) have signed informed consent documents*
- Confirmation of cytomegalovirus (CMV) by urine polymerase chain reaction (PCR) testing
- Infant </= 30 days of age at initiation of study drug
- Weight at study enrollment >/= 1775 grams
- Gestational age >/= 32 weeks at birth
- There is a screening informed consent for screening phase of study participation, and a treatment informed consent for treatment phase of study participation.
Who cannot join
- Symptomatic congenital cytomegalovirus (CMV) disease*
- Sensorineural hearing deficits as detected by formal brainstem evoked response (not a screening auditory brainstem response (abr)) of known etiology other than CMV
- Prior or current receipt of ganciclovir, valganciclovir, foscarnet, cidofovir, brincidofovir, maribavir, or letermovir
- Maternal receipt of CMV hyperimmune globulin during pregnancy
- Breastfeeding from mother who is receiving ganciclovir, valganciclovir, foscarnet, cidofovir, brincidofovir, maribavir, or letermovir
- Gastrointestinal abnormality which might preclude absorption of an oral medication (e.g., a history of necrotizing enterocolitis)
Show all 9Show fewer
- Infants known to be born to women who are HIV positive (HIV testing is not required for study entry)
- Current receipt of other investigational drugs
- Symptomatic disease is defined as one or more of the following: 1) thrombocytopenia, if known; 2) petechiae; 3) hepatomegaly; 4) splenomegaly; 5) intrauterine growth restriction; 6) hepatitis (elevated transaminases and/or direct bilirubin), if known; 7) central nervous system involvement of the CMV disease (such as microcephaly; radiographic abnormalities indicative of CMV CNS disease, if known; abnormal CSF indices for age, if known; chorioretinitis, if known; and/or positive CMV PCR from CSF, if known).
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Alabama - Children's of Alabama - Clinical Virology
Birmingham, Alabama, 35233-1711
Carolinas Medical Center - Pediatrics - Infectious Diseases
Charlotte, North Carolina, 28203-5812
Nationwide Children's Hospital - Neonatology - Center for Perinatal Research
Columbus, Ohio, 43205-2664
Texas Medical Center - Texas Children's Hospital
Houston, Texas, 77030-2303
University of Mississippi - Children's Infectious Diseases
Jackson, Mississippi, 39216-4505
Arkansas Children's Hospital - Infectious Diseases
Little Rock, Arkansas, 72202
University of Louisville School of Medicine - Norton Children's Hospital - Infectious Diseases
Louisville, Kentucky, 40202
Children's Hospital of Pittsburgh of UPMC - Pediatric Infectious Diseases
Pittsburgh, Pennsylvania, 15224-1529
Washington University School of Medicine in St. Louis - Center for Clinical Studies
St Louis, Missouri, 63110-1010
About this study
Official title: A Phase II, Single Stage, Single-Arm Investigation of Oral Valganciclovir Therapy in Infants With Asymptomatic Congenital Cytomegalovirus Infection
This is a phase II, open-label trial to evaluate valganciclovir as a treatment to prevent development of sensorineural hearing loss (SNHL) in infants with asymptomatic congenital cytomegalovirus (CMV) infection. The trial will be conducted in two phases - screening of newborns to identify eligible subjects, and treatment of those newborns who have confirmed CMV infection at birth but without outward manifestations of congenital CMV infection. 229 newborns with confirmed CMV infection but without baseline SNHL and who meet all inclusion/exclusion criteria will be enrolled into the treatment phase. Study duration is 5 years. Primary objective of this study is to estimate the proportion of subjects with asymptomatic congenital CMV infection who, following treatment with 4 months of oral valganciclovir, develop SNHL by 6 months of life.
Read the detailed description
This is a phase II, open-label trial to evaluate valganciclovir as a treatment to prevent development of sensorineural hearing loss (SNHL) in infants with asymptomatic congenital cytomegalovirus (CMV) infection. The trial will be conducted in two phases - screening of newborns to identify eligible subjects, and treatment of those newborns who have confirmed CMV infection at birth but without outward manifestations of congenital CMV infection. Approximately 48,250 newborn infants with no outward manifestations of congenital CMV infection will be screened to detect approximately 241 neonates with asymptomatic congenital CMV infection; these 241 newborns then will have audiology examinations to determine baseline hearing, with approximately 229 having normal hearing in both ears. Those 229 newborns with confirmed CMV infection but without baseline SNHL and who meet all inclusion/exclusion criteria will be enrolled into the treatment phase. Enrolled subjects will be treated for four months with oral valganciclovir (16 mg/kg/dose, administered two times per day). Audiologic assessments will be made during the Screening Period and Study Months 4 (end of treatment), 6, 12, and 18. Treated infants will be followed for safety throughout the first 6 months of the study (including for 2 months post-treatment). Study duration is 5 years. Primary objective of this study is to estimate the proportion of subjects with asymptomatic congenital CMV infection who, following treatment with 4 months of oral valganciclovir, develop sensorineural hearing loss (SNHL) by 6 months of life. Secondary objectives are to: 1) define the safety and tolerability of valganciclovir in enrolled subjects, 2) estimate the proportion of subjects with asymptomatic congenital CMV infection who, following treatment with 4 months of oral valganciclovir, develop SNHL over the first 18 months of life.
- Conditions
- Congenital Cytomegalovirus Infection
- Being tested
- Valganciclovir
- Keywords
- Asymptomatic, Congenital CMV Infection, Valganciclovir Therapy
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValganciclovirDrug
Valganciclovir, 16 mg/kg/dose given orally twice daily for four months
| Study group | Role | What they receive |
|---|---|---|
| Confirmed congenital CMV without baseline SNHL | Experimental | Valganciclovir 16 mg/kg/dose orally twice daily for four months, n=229 Receives: Drug: Valganciclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants Developing Sensorineural Hearing Loss (SNHL) in at Least One Ear Between Baseline and Study Month 6
Audiologic assessments were made during the Screening Period and Study Months 4 (end of treatment), 6, 12, and 18. A single, independent study audiologist assessed the audiology test battery for each subject and assigned each ear the classifications of normal hearing, mild hearing loss, moderate hearing loss, severe hearing loss, or profound hearing loss based upon their hearing thresholds (in decibels). SNHL between baseline and Study Month 6 is defined as both ears with normal hearing at baseline, then at least one ear with sensorineural hearing loss (SNHL) at the 6 month follow-up.
Measured: Between baseline and study month 6
Secondary outcomes (17)
Number of Participants With Absolute Neutrophil Counts Below 500/mm^3
Blood was collected for assessments of hematology and absolute neutrophil count was assessed at each study visit through Month 5
Measured: Day 1 through Study month 5
Number of Participants With Adverse Events Leading to Permanent Discontinuation of Valganciclovir Therapy, or Any Adverse Event That is Not Recovered / Not Resolved
A count of participants discontinued from valganciclovir therapy due to adverse events were reported during the therapy period, and the count of participants with adverse events not recovered/not resolved were reported throughout the adverse event period.
Measured: Day 1 through Study month 6
Number of Participants With Grade 3 or Higher Safety Laboratory Adverse Events
At each study visit from the receipt of first dose of study drug and continuing through four weeks following the final dose of study drug, the participants were assessed for any adverse events. Lab parameters included ALT, creatinine, direct bilirubin, white blood cell count with differential, hemoglobin, platelets count. Abnormal laboratory values were reported as an AE if they worsened in severity from baseline, per the grading definitions provided in the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
Measured: From day 1 through study month 6
Number of Participants With Serious Adverse Events
Serious adverse events were those defined as: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, a congenital anomaly/birth defect, or were important medical events that may not result in death, be life-threatening, or require hospitalizations may be considered serious when, based upon appropriate medical judgment they may jeopardize the participant and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Measured: From day 1 through study month 6
Number of Participants With Grade 3 or Higher Unsolicited Adverse Events Assessed by Adapted From DAIDS Toxicity Tables
At each study visit from the receipt of first dose of study drug and continuing through four weeks following the final dose of study drug, the participants were assessed for any adverse events. Lab parameters included ALT, creatinine, direct bilirubin, white blood cell count with differential, hemoglobin, platelets count. Abnormal laboratory values were reported as an AE if they worsened in severity from baseline, per the grading definitions provided in the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events.
Measured: From day 1 through study month 6
Number of Participants With Mild Worsened Hearing, Represented by the Ear That Has the Larger Degree of Worsening
Audiologic assessments were made during the Screening Period and Study Months 4 (end of treatment), 6, 12, and 18. A single, independent study audiologist assessed the audiology test battery for each participant and assigned each ear the classifications of normal hearing, mild hearing loss, moderate hearing loss, severe hearing loss, or profound hearing loss based upon their hearing thresholds (in decibels). SNHL between baseline and Study Month 18 is defined as both ears with normal hearing at baseline, then at least one ear with sensorineural hearing loss (SNHL) at the 18 month follow-up.
Measured: Screening and Study Months 4, 6, 8 and 12
Number of Participants With Moderate Worsened Hearing, Represented by the Ear That Has the Larger Degree of Worsening
Audiologic assessments were made during the Screening Period and Study Months 4 (end of treatment), 6, 12, and 18. A single, independent study audiologist assessed the audiology test battery for each subject and assigned each ear the classifications of normal hearing, mild hearing loss, moderate hearing loss, severe hearing loss, or profound hearing loss based upon their hearing thresholds (in decibels). SNHL between baseline and Study Month 18 is defined as both ears with normal hearing at baseline, then at least one ear with sensorineural hearing loss (SNHL) at the 18 month follow-up.
Measured: Screening and Study Months 4, 6, 8 and 12
Number of Participants With Profound Worsened Hearing, Represented by the Ear That Has the Larger Degree of Worsening
Audiologic assessments were made during the Screening Period and Study Months 4 (end of treatment), 6, 12, and 18. A single, independent study audiologist assessed the audiology test battery for each participant and assigned each ear the classifications of normal hearing, mild hearing loss, moderate hearing loss, severe hearing loss, or profound hearing loss based upon their hearing thresholds (in decibels). SNHL between baseline and Study Month 18 is defined as both ears with normal hearing at baseline, then at least one ear with sensorineural hearing loss (SNHL) at the 18 month follow-up.
Measured: Study Months 4, 6, 8 and 12
Number of Participants With Severe Worsened Hearing, Represented by the Ear That Has the Larger Degree of Worsening
Audiologic assessments were made during the Screening Period and Study Months 4 (end of treatment), 6, 12, and 18. A single, independent study audiologist assessed the audiology test battery for each participant and assigned each ear the classifications of normal hearing, mild hearing loss, moderate hearing loss, severe hearing loss, or profound hearing loss based upon their hearing thresholds (in decibels). SNHL between baseline and Study Month 18 is defined as both ears with normal hearing at baseline, then at least one ear with sensorineural hearing loss (SNHL) at the 18 month follow-up.
Measured: Study Months 4, 6, 8 and 12
Number of Participants With Sensorineural Hearing Loss in at Least One Ear Through Study Month 4
Audiologic assessments were made during the Screening Period and Study Months 4 (end of treatment), 6, 12, and 18. A single, independent study audiologist assessed the audiology test battery for each participant and assigned each ear the classifications of normal hearing, mild hearing loss, moderate hearing loss, severe hearing loss, or profound hearing loss based upon their hearing thresholds (in decibels). SNHL between baseline and Study Month 4 is defined as both ears with normal hearing at baseline, then at least one ear with sensorineural hearing loss (SNHL) at the 4 month follow-up.
Measured: Between screening and study month 4
Number of Participants With Sensorineural Hearing Loss in at Least One Ear Through Study Month 12
Audiologic assessments were made during the Screening Period and Study Months 4 (end of treatment), 6, 12, and 18. A single, independent study audiologist assessed the audiology test battery for each participant and assigned each ear the classifications of normal hearing, mild hearing loss, moderate hearing loss, severe hearing loss, or profound hearing loss based upon their hearing thresholds (in decibels). SNHL between baseline and Study Month 12 is defined as both ears with normal hearing at baseline, then at least one ear with sensorineural hearing loss (SNHL) at the 12 month follow-up.
Measured: Between screening and study month 12
Number of Participants With Sensorineural Hearing Loss in at Least One Ear Through Study Month 18
Audiologic assessments were made during the Screening Period and Study Months 4 (end of treatment), 6, 12, and 18. A single, independent study audiologist assessed the audiology test battery for each participant and assigned each ear the classifications of normal hearing, mild hearing loss, moderate hearing loss, severe hearing loss, or profound hearing loss based upon their hearing thresholds (in decibels). SNHL between baseline and Study Month 18 is defined as both ears with normal hearing at baseline, then at least one ear with sensorineural hearing loss (SNHL) at the 18 month follow-up.
Measured: Between screening and study month 18
Number of Participants With Transaminase Elevation During Treatment > / = 2 Times the Baseline Value
Blood was collected for assessments of clinical chemistry and alanine aminotransferase (ALT) was assessed at screening, week 2, Week 4, Week 6, Week 8, Week 10, Week 12, Month 4, Month 5, and Month 6
Measured: Baseline, weeks 2, 4, 6, 8, 10, 12, months 4, 5 and 6.
Number of Ears of Mild Worsened Hearing
Audiologic assessments were made during the Screening Period and Study Months 4 (end of treatment), 6, 12, and 18. A single, independent study audiologist assessed the audiology test battery for each participant and assigned each ear the classifications of normal hearing, mild hearing loss, moderate hearing loss, severe hearing loss, or profound hearing loss based upon their hearing thresholds (in decibels).
Measured: Screening and Study Months 4, 6, 12, and 18
Number of Ears of Moderate Worsened Hearing
Audiologic assessments were made during the Screening Period and Study Months 4 (end of treatment), 6, 12, and 18. A single, independent study audiologist assessed the audiology test battery for each participant and assigned each ear the classifications of normal hearing, mild hearing loss, moderate hearing loss, severe hearing loss, or profound hearing loss based upon their hearing thresholds (in decibels).
Measured: Screening and Study Months 4, 6, 12, and 18
Number of Ears of Profound Worsened Hearing
Audiologic assessments were made during the Screening Period and Study Months 4 (end of treatment), 6, 12, and 18. A single, independent study audiologist assessed the audiology test battery for each participant and assigned each ear the classifications of normal hearing, mild hearing loss, moderate hearing loss, severe hearing loss, or profound hearing loss based upon their hearing thresholds (in decibels).
Measured: Screening and Study Months 4, 6, 12, and 18
Number of Ears of Severe Worsened Hearing
Audiologic assessments were made during the Screening Period and Study Months 4 (end of treatment), 6, 12, and 18. A single, independent study audiologist assessed the audiology test battery for each participant and assigned each ear the classifications of normal hearing, mild hearing loss, moderate hearing loss, severe hearing loss, or profound hearing loss based upon their hearing thresholds (in decibels).
Measured: Screening and Study Months 4, 6, 12, and 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start21 Aug 2019
- Primary completion5 Nov 2020
- Study completion5 Nov 2020
Why it stopped: Safety signal
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Congenital Cytomegalovirus InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301415
- Sponsor's protocol ID
- 16-0095
- Status last verified
- Oct 2018
- First submitted
- 28 Sep 2017
- Last updated
- 26 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single Stage, Single-Arm Investigation of Oral Valganciclovir Therapy in Infants With Asymptomatic Congenital Cytomegalovirus Infection
- ClinicalTrials.gov ID
- NCT03301415
- Acronym / sponsor ID
- 16-0095
- Conditions
- Congenital Cytomegalovirus Infection
- Keywords
- Asymptomatic, Congenital CMV Infection, Valganciclovir Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Safety signal
- Enrolment
- 7 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 21 Aug 2019 (actual)
- Primary completion
- 5 Nov 2020 (actual)
- Study completion
- 5 Nov 2020 (actual)
- First posted
- 4 Oct 2017 (actual)
- Results
- Posted 26 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II, open-label trial to evaluate valganciclovir as a treatment to prevent development of sensorineural hearing loss (SNHL) in infants with asymptomatic congenital cytomegalovirus (CMV) infection. The trial will be conducted in two phases - screening of newborns to identify eligible subjects, and treatment of those newborns who have confirmed CMV infection at birth but without outward manifestations of congenital CMV infection. 229 newborns with confirmed CMV infection but without baseline SNHL and who meet all inclusion/exclusion criteria will be enrolled into the treatment phase. Study duration is 5 years. Primary objective of this study is to estimate the proportion of subjects with asymptomatic congenital CMV infection who, following treatment with 4 months of oral valganciclovir, develop SNHL by 6 months of life.
Detailed description
This is a phase II, open-label trial to evaluate valganciclovir as a treatment to prevent development of sensorineural hearing loss (SNHL) in infants with asymptomatic congenital cytomegalovirus (CMV) infection. The trial will be conducted in two phases - screening of newborns to identify eligible subjects, and treatment of those newborns who have confirmed CMV infection at birth but without outward manifestations of congenital CMV infection. Approximately 48,250 newborn infants with no outward manifestations of congenital CMV infection will be screened to detect approximately 241 neonates with asymptomatic congenital CMV infection; these 241 newborns then will have audiology examinations to determine baseline hearing, with approximately 229 having normal hearing in both ears. Those 229 newborns with confirmed CMV infection but without baseline SNHL and who meet all inclusion/exclusion criteria will be enrolled into the treatment phase. Enrolled subjects will be treated for four months with oral valganciclovir (16 mg/kg/dose, administered two times per day). Audiologic assessments will be made during the Screening Period and Study Months 4 (end of treatment), 6, 12, and 18. Treated infants will be followed for safety throughout the first 6 months of the study (including for 2 months post-treatment). Study duration is 5 years. Primary objective of this study is to estimate the proportion of subjects with asymptomatic congenital CMV infection who, following treatment with 4 months of oral valganciclovir, develop sensorineural hearing loss (SNHL) by 6 months of life. Secondary objectives are to: 1) define the safety and tolerability of valganciclovir in enrolled subjects, 2) estimate the proportion of subjects with asymptomatic congenital CMV infection who, following treatment with 4 months of oral valganciclovir, develop SNHL over the first 18 months of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Confirmed congenital CMV without baseline SNHL | Experimental | Drug: ValganciclovirValganciclovir 16 mg/kg/dose orally twice daily for four months, n=229 |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Parent(s)/legal guardian(s) have signed informed consent documents*
- Confirmation of cytomegalovirus (CMV) by urine polymerase chain reaction (PCR) testing
- Infant </= 30 days of age at initiation of study drug
- Weight at study enrollment >/= 1775 grams
- Gestational age >/= 32 weeks at birth
Key exclusion criteria (9 listed)
- Symptomatic congenital cytomegalovirus (CMV) disease*
- Sensorineural hearing deficits as detected by formal brainstem evoked response (not a screening auditory brainstem response (abr)) of known etiology other than CMV
- Prior or current receipt of ganciclovir, valganciclovir, foscarnet, cidofovir, brincidofovir, maribavir, or letermovir
- Maternal receipt of CMV hyperimmune globulin during pregnancy
- Breastfeeding from mother who is receiving ganciclovir, valganciclovir, foscarnet, cidofovir, brincidofovir, maribavir, or letermovir
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ValganciclovirValganciclovir, 16 mg/kg/dose given orally twice daily for four months | Drug | Confirmed congenital CMV without baseline SNHL |
Primary outcome
The Number of Participants Developing Sensorineural Hearing Loss (SNHL) in at Least One Ear Between Baseline and Study Month 6
Time frame: Between baseline and study month 6
Audiologic assessments were made during the Screening Period and Study Months 4 (end of treatment), 6, 12, and 18. A single, independent study audiologist assessed the audiology test battery for each subject and assigned each ear the classifications of normal hearing, mild hearing loss, moderate hearing loss, severe hearing loss, or profound hearing loss based upon their hearing thresholds (in decibels). SNHL between baseline and Study Month 6 is defined as both ears with normal hearing at baseline, then at least one ear with sensorineural hearing loss (SNHL) at the 6 month follow-up.
17 secondary outcomes
Number of Participants With Absolute Neutrophil Counts Below 500/mm^3
Time frame: Day 1 through Study month 5
Number of Participants With Adverse Events Leading to Permanent Discontinuation of Valganciclovir Therapy, or Any Adverse Event That is Not Recovered / Not Resolved
Time frame: Day 1 through Study month 6
Number of Participants With Grade 3 or Higher Safety Laboratory Adverse Events
Time frame: From day 1 through study month 6
Number of Participants With Serious Adverse Events
Time frame: From day 1 through study month 6
Number of Participants With Grade 3 or Higher Unsolicited Adverse Events Assessed by Adapted From DAIDS Toxicity Tables
Time frame: From day 1 through study month 6
Number of Participants With Mild Worsened Hearing, Represented by the Ear That Has the Larger Degree of Worsening
Time frame: Screening and Study Months 4, 6, 8 and 12
Number of Participants With Moderate Worsened Hearing, Represented by the Ear That Has the Larger Degree of Worsening
Time frame: Screening and Study Months 4, 6, 8 and 12
Number of Participants With Profound Worsened Hearing, Represented by the Ear That Has the Larger Degree of Worsening
Time frame: Study Months 4, 6, 8 and 12
Number of Participants With Severe Worsened Hearing, Represented by the Ear That Has the Larger Degree of Worsening
Time frame: Study Months 4, 6, 8 and 12
Number of Participants With Sensorineural Hearing Loss in at Least One Ear Through Study Month 4
Time frame: Between screening and study month 4
Number of Participants With Sensorineural Hearing Loss in at Least One Ear Through Study Month 12
Time frame: Between screening and study month 12
Number of Participants With Sensorineural Hearing Loss in at Least One Ear Through Study Month 18
Time frame: Between screening and study month 18
Number of Participants With Transaminase Elevation During Treatment > / = 2 Times the Baseline Value
Time frame: Baseline, weeks 2, 4, 6, 8, 10, 12, months 4, 5 and 6.
Number of Ears of Mild Worsened Hearing
Time frame: Screening and Study Months 4, 6, 12, and 18
Number of Ears of Moderate Worsened Hearing
Time frame: Screening and Study Months 4, 6, 12, and 18
Number of Ears of Profound Worsened Hearing
Time frame: Screening and Study Months 4, 6, 12, and 18
Number of Ears of Severe Worsened Hearing
Time frame: Screening and Study Months 4, 6, 12, and 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Cytomegalovirus Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Valganciclovir in people with Congenital Cytomegalovirus Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Participants Developing Sensorineural Hearing Loss (SNHL) in at Least One Ear Between Baseline and Study Month 6 (time frame: Between baseline and study month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2023.